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PHSS PUPSIT Annex 1 Impact Statement 2017

17 July 2017   (0 Comments)
Posted by: Tamsin Marshall
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Impact Statement - Annex 1 – (PUPSIT)
(Pre-use & Post-use Sterilizing Filter Integrity Testing)




In January 2017 we issued an Impact Statement indicating that, “After several delays we fully expect the full revised Annex 1 to be issued for a 3 month public consultation during Q1 2017 and for the final document to be published soon after the 3 month consultation period”. Well, it hasn’t happened yet, but be sure that it will (now possibly in Q3 2017). The document is currently with EMA having completed the initial drafting processes..


During the PHSS June 2017 Steriles conference we heard from Regulators that PUPSIT will  definitely continue to be included (and attention to it reinforced) in the revised Annex 1 . Whilst it remains an EU regulatory expectation the USA has no such legal requirement, although it is believed that there is strong support for it within influential elements of the US FDA.

Why is this?
• Assurance of sterility has always been a priority for regulators and industry / healthcare professionals and of course of prime importance to the patient.
• In recent years there have been a number of inspections of companies manufacturing within EU and USA which have identified unacceptable assurance of sterility and subsequent risk to patient. These have led to withdrawal of manufacturing licences, multi batch recalls. One such case, in a “GMP mature country” resulted in a company
CEO being sentenced to a 9 year prison term.

Inspectional observations in these as well as less serious cases have included: -
❖ Poorly designed facilities and / or processes
❖ Poorly controlled monitoring regimes
❖ Investigations and risk assessments
❖ Lack / application of knowledge

PUPSIT could easily be seen to fit all of the above points.


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